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How to Find 0009-0016-12 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "0009-0016-12",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0016-12)  / 4 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "00009-0016-12",
      "ProductNDC": "0009-0016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Solu-cortef",
      "NonProprietaryName": "Hydrocortisone Sodium Succinate",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "19550427",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA009866",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/4mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19550427",
      "SamplePackage": "N",
      "IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
      "Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
    },
    {
      "NDCCode": "0067-0016-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (0067-0016-24)  > 12 PILL in 1 BLISTER PACK",
      "NDC11Code": "00067-0016-24",
      "ProductNDC": "0067-0016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ex-lax",
      "ProprietaryNameSuffix": "Maximum Strength Stimulant Laxative",
      "NonProprietaryName": "Sennosides",
      "DosageFormName": "PILL",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120101",
      "EndMarketingDate": "20181130",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "GlaxoSmithKline Consumer Healthcare Holdings (US) LLC",
      "SubstanceName": "SENNOSIDES",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120101",
      "EndMarketingDatePackage": "20181130",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0067-0016-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (0067-0016-48)  > 12 PILL in 1 BLISTER PACK",
      "NDC11Code": "00067-0016-48",
      "ProductNDC": "0067-0016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ex-lax",
      "ProprietaryNameSuffix": "Maximum Strength Stimulant Laxative",
      "NonProprietaryName": "Sennosides",
      "DosageFormName": "PILL",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120101",
      "EndMarketingDate": "20181130",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "GlaxoSmithKline Consumer Healthcare Holdings (US) LLC",
      "SubstanceName": "SENNOSIDES",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-10-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20120101",
      "EndMarketingDatePackage": "20180930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0220-0016-12",
      "PackageDescription": "60 mL in 1 BOTTLE, GLASS (0220-0016-12)",
      "NDC11Code": "00220-0016-12",
      "ProductNDC": "0220-0016",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Wormwood",
      "DosageFormName": "PELLET",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Laboratoires Boiron",
      "SubstanceName": "WORMWOOD",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10736-016-12",
      "PackageDescription": "8750.9 L in 1 CYLINDER (10736-016-12)",
      "NDC11Code": "10736-0016-12",
      "ProductNDC": "10736-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Air",
      "NonProprietaryName": "Air",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "19630101",
      "MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
      "LabelerName": "Medical-Technical Gases, Inc.",
      "SubstanceName": "AIR",
      "StrengthNumber": "1000",
      "StrengthUnit": "mL/L",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "13668-016-12",
      "PackageDescription": "120 TABLET in 1 BOTTLE (13668-016-12) ",
      "NDC11Code": "13668-0016-12",
      "ProductNDC": "13668-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levetiracetam",
      "NonProprietaryName": "Levetiracetam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078858",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "LEVETIRACETAM",
      "StrengthNumber": "750",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20090115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
      "Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.       250 mg tablets: FD&C Blue #2 Lake of indigo carmine.       500 mg tablets: Ferric oxide yellow.       750 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow. Meets USP Dissolution Test 3."
    },
    {
      "NDCCode": "25682-016-12",
      "PackageDescription": "12 VIAL in 1 CARTON (25682-016-12)  / 1 mL in 1 VIAL (25682-016-01) ",
      "NDC11Code": "25682-0016-12",
      "ProductNDC": "25682-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Strensiq",
      "NonProprietaryName": "Asfotase Alfa",
      "DosageFormName": "SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20151023",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125513",
      "LabelerName": "Alexion Pharmaceuticals, Inc.",
      "SubstanceName": "ASFOTASE ALFA",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151023",
      "SamplePackage": "N",
      "IndicationAndUsage": "STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).",
      "Description": "Asfotase alfa is a tissue nonspecific alkaline phosphatase (TNSALP) produced by recombinant DNA technology in a Chinese hamster ovary cell line. Asfotase alfa is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human TNSALP, the human immunoglobulin G1 Fc domain and a deca-aspartate peptide used as a bone targeting domain. The two polypeptide chains are covalently linked by two disulfide bonds. STRENSIQ (asfotase alfa) injection is a sterile, preservative-free, nonpyrogenic, clear, slightly opalescent or opalescent, colorless to slightly yellow, with few small translucent or white particles, aqueous solution for subcutaneous administration. STRENSIQ is supplied in glass single-dose vials containing asfotase alfa; dibasic sodium phosphate, heptahydrate; monobasic sodium phosphate, monohydrate; and sodium chloride at a pH between 7.2 and 7.6. Table 5 describes the content of STRENSIQ vial presentations."
    },
    {
      "NDCCode": "33342-016-12",
      "PackageDescription": "100 TABLET in 1 CARTON (33342-016-12) ",
      "NDC11Code": "33342-0016-12",
      "ProductNDC": "33342-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amlodipine",
      "NonProprietaryName": "Amlodipine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120413",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA201380",
      "LabelerName": "Macleods Pharmaceuticals Limited",
      "SubstanceName": "AMLODIPINE BESYLATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20120413",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37000-016-12",
      "PackageDescription": "12 TABLET in 1 BOTTLE, PLASTIC (37000-016-12)",
      "NDC11Code": "37000-0016-12",
      "ProductNDC": "37000-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pepto-bismol To Go",
      "NonProprietaryName": "Bismuth Subsalicylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part335",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "BISMUTH SUBSALICYLATE",
      "StrengthNumber": "262",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "58933-016-12",
      "PackageDescription": "12 TABLET in 1 BOTTLE, PLASTIC (58933-016-12) ",
      "NDC11Code": "58933-0016-12",
      "ProductNDC": "58933-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Pepto-bismol To Go",
      "NonProprietaryName": "Bismuth Subsalicylate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part335",
      "LabelerName": "Procter & Gamble Manufactura S de RL de CV",
      "SubstanceName": "BISMUTH SUBSALICYLATE",
      "StrengthNumber": "262",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20120301",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "60429-016-12",
      "PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-016-12) ",
      "NDC11Code": "60429-0016-12",
      "ProductNDC": "60429-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mycophenolic Acid",
      "NonProprietaryName": "Mycophenolic Acid",
      "DosageFormName": "TABLET, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120821",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091558",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "MYCOPHENOLATE SODIUM",
      "StrengthNumber": "180",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1) . Use in combination with cyclosporine and corticosteroids. ( 1.1) .",
      "Description": "Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as ( E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its molecular formula is C 17H 19O 6Na. The molecular weight is 342.32 g/mol and the structural formula is. Mycophenolic acid, as the sodium salt, is a white to off-white powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, hypromellose, methylcellulose, polyethylene glycol, sodium lauryl sulfate and stearic acid. The enteric coating of the tablet consists of ferric oxide red (360 mg), ferric oxide yellow, indigotine al lake (180 mg), methacrylic acid and ethyl acrylate copolymer dispersion, talc, titanium dioxide, and triethyl citrate."
    },
    {
      "NDCCode": "63148-016-12",
      "PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (63148-016-12) ",
      "NDC11Code": "63148-0016-12",
      "ProductNDC": "63148-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kitchen Lemon Zest Antibacterial Foaming Hand",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "SOAP",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190820",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Apollo Health and Beauty Care Inc.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1.3",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20190820",
      "SamplePackage": "N",
      "IndicationAndUsage": "for washing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "69771-016-12",
      "PackageDescription": "5 g in 1 PACKET (69771-016-12) ",
      "NDC11Code": "69771-0016-12",
      "ProductNDC": "69771-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Geri-gentle Petrolatum",
      "NonProprietaryName": "White Petrolatum",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130923",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Geri-gentle corporation",
      "SubstanceName": "PETROLATUM",
      "StrengthNumber": "100",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2025-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130923",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged."
    },
    {
      "NDCCode": "70737-016-12",
      "PackageDescription": "473 mL in 1 BOTTLE (70737-016-12) ",
      "NDC11Code": "70737-0016-12",
      "ProductNDC": "70737-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Fluoride Dental Treatment Rinse",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20211019",
      "EndMarketingDate": "20230930",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "DR Products",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2023-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20211019",
      "EndMarketingDatePackage": "20230930",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71819-016-12",
      "PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (71819-016-12) ",
      "NDC11Code": "71819-0016-12",
      "ProductNDC": "71819-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dermaharmony Zinc Therapy",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210905",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "D3 Development, Inc.",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210905",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis."
    },
    {
      "NDCCode": "71930-016-12",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12) ",
      "NDC11Code": "71930-0016-12",
      "ProductNDC": "71930-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quinidine Gluconate",
      "NonProprietaryName": "Quinidine Gluonate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212589",
      "LabelerName": "Eywa Pharma Inc",
      "SubstanceName": "QUINIDINE GLUCONATE",
      "StrengthNumber": "324",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2022-03-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220320",
      "SamplePackage": "N",
      "IndicationAndUsage": "Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued. Reduction of frequency of relapse into atrial fibrillation/flutter Chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have had previous episodes of atrial fibrillation/flutter that were so frequent and poorly tolerated as to outweigh, in the judgment of the physician and the patient, the risks of prophylactic therapy with quinidine gluconate. The increased risk of death should specifically be considered. Quinidine gluconate should be used only after alternative measures (e.g., use of other drugs to control the ventricular rate) have been found to be inadequate. In patients with histories of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy, and a single recurrence should not be interpreted as therapeutic failure. Suppression of ventricular arrhythmias Quinidine gluconate is also indicated for the suppression of recurrent documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of quinidine, its use with ventricular arrhythmias of lesser severity is generally not recommended, and treatment of patients with asymptomatic ventricular premature contractions should be avoided. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise. Antiarrhythmic drugs (including quinidine gluconate) have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2  C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, alcohol and sodium alginate. Meets USP Dissolution Test 6."
    },
    {
      "NDCCode": "73212-016-12",
      "PackageDescription": "100 g in 1 BOTTLE (73212-016-12) ",
      "NDC11Code": "73212-0016-12",
      "ProductNDC": "73212-016",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Thymosin Beta-4 Acetate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200801",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Qingdao Biopeptek Co., Ltd.",
      "SubstanceName": "THYMOSIN .BETA.-4",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-12",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "01-AUG-20"
    },
    {
      "NDCCode": "73774-016-12",
      "PackageDescription": ".035 kg in 1 POUCH (73774-016-12) ",
      "NDC11Code": "73774-0016-12",
      "ProductNDC": "73774-016",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Testosterone Cypionate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20230101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "SHAKTI LIFESCIENCE PRIVATE LIMITED",
      "SubstanceName": "TESTOSTERONE CYPIONATE",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "DEASchedule": "CIII",
      "Status": "Unfinished",
      "LastUpdate": "2026-05-11",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "12-JAN-24"
    },
    {
      "NDCCode": "74743-016-12",
      "PackageDescription": "3800 g in 1 BOTTLE (74743-016-12) ",
      "NDC11Code": "74743-0016-12",
      "ProductNDC": "74743-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Alcohol Free Sanitizing",
      "NonProprietaryName": "Alcohol Free Sanitizing",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200420",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Guangzhou Joy Claire Biological Technology Co., Ltd",
      "SubstanceName": "BENZALKONIUM CHLORIDE; POLYAMINOPROPYL BIGUANIDE",
      "StrengthNumber": ".04; .1",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200420",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sanitizing for surfaces of hard objects in hospitals, homes and public areas, full skin surface,surgeres, fabrics and other surfaces of porous objects."
    },
    {
      "NDCCode": "75086-016-12",
      "PackageDescription": "3800 mL in 1 BOTTLE (75086-016-12) ",
      "NDC11Code": "75086-0016-12",
      "ProductNDC": "75086-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Air Raid Card Wash Free Disinfectant",
      "NonProprietaryName": "Air Raid Card Wash Free Disinfectant",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200420",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Jiangsu Manwei Pharmaceutical Co.,Ltd",
      "SubstanceName": "HYPOCHLOROUS ACID",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200420",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "80948-016-12",
      "PackageDescription": "4 BOTTLE in 1 PACKAGE (80948-016-12)  / 80 mL in 1 BOTTLE",
      "NDC11Code": "80948-0016-12",
      "ProductNDC": "80948-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Puroma Foaming Hand Sanitizer Alcohol Free With Fragrance Floral",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210427",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "ZENITH MICRO CONTROL",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "130",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210427",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps eliminate bacteria on hands."
    },
    {
      "NDCCode": "82804-016-12",
      "PackageDescription": "12 TABLET in 1 BOTTLE (82804-016-12) ",
      "NDC11Code": "82804-0016-12",
      "ProductNDC": "82804-016",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hydrochloride",
      "NonProprietaryName": "Phenazopyridine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230508",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231004",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phenazopyridine HCL is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).",
      "Description": "Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl oral tablets contain the following inactive ingredients: Croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, maize (corn starch), microcrystalline cellulose, polyethylene glycol, povidone and pregelatinized starch."
    },
    {
      "NDCCode": "83511-016-12",
      "PackageDescription": ".001 kg in 1 DRUM (83511-016-12) ",
      "NDC11Code": "83511-0016-12",
      "ProductNDC": "83511-016",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Clemastine Fumarate",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20250929",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "STHREE CHEMICALS PRIVATE LIMITED",
      "SubstanceName": "CLEMASTINE FUMARATE",
      "StrengthNumber": "35",
      "StrengthUnit": "kg/35kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-10",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "29-SEP-25"
    },
    {
      "NDCCode": "83629-016-12",
      "PackageDescription": "355 mL in 1 BOTTLE, PLASTIC (83629-016-12) ",
      "NDC11Code": "83629-0016-12",
      "ProductNDC": "83629-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nexxgen 91% Rubbing Alcohol",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230801",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "A & A Nexxgen LLC",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "91",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2024-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230801",
      "SamplePackage": "N",
      "IndicationAndUsage": " first aid to help prevent the risk of infection in minor cuts, scrapes and burns."
    },
    {
      "NDCCode": "83702-016-12",
      "PackageDescription": "6 PATCH in 1 BAG (83702-016-12)  / 2.1 g in 1 PATCH (83702-016-11) ",
      "NDC11Code": "83702-0016-12",
      "ProductNDC": "83702-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Rotosxika Varicoce Veins Plaster",
      "NonProprietaryName": "Aesculus Chinensis, Arnica",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20230601",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Puning Xinhua Trade Co., Ltd.",
      "SubstanceName": "AESCULUS CHINENSIS WHOLE; ARNICA CORDIFOLIA WHOLE",
      "StrengthNumber": "4; 3",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Use to: Temporarily alleviate discomfort related to varicose veins: lower limb spasms, limb soreness, venous dilation, venous congestion, leg fatigue."
    },
    {
      "NDCCode": "84165-016-12",
      "PackageDescription": "12 BAG in 1 BOX (84165-016-12)  / 21 g in 1 BAG (84165-016-01) ",
      "NDC11Code": "84165-0016-12",
      "ProductNDC": "84165-016",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sumifun Lidocaine Pain Relief Gel-patch",
      "NonProprietaryName": "Lidocaine",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250829",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Guangzhou Zhupuyou E-commerce Co., Ltd",
      "SubstanceName": "LIDOCAINE",
      "StrengthNumber": ".04",
      "StrengthUnit": "g/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-09-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250829",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders,elbows."
    },
    {
      "NDCCode": "0009-0171-12",
      "PackageDescription": "60 TABLET in 1 BOTTLE (0009-0171-12)",
      "NDC11Code": "00009-0171-12",
      "ProductNDC": "0009-0171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Micronase",
      "NonProprietaryName": "Glyburide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19840501",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017498",
      "LabelerName": "Pharmacia and Upjohn Company",
      "SubstanceName": "GLYBURIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-07-14"
    },
    {
      "NDCCode": "0009-0306-12",
      "PackageDescription": "25 VIAL, MULTI-DOSE in 1 PACKAGE (0009-0306-12)  / 5 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00009-0306-12",
      "ProductNDC": "0009-0306",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Depo-medrol",
      "NonProprietaryName": "Methylprednisolone Acetate",
      "DosageFormName": "INJECTION, SUSPENSION",
      "RouteName": "INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE",
      "StartMarketingDate": "19590528",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA011757",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "METHYLPREDNISOLONE ACETATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19590528",
      "SamplePackage": "N",
      "IndicationAndUsage": "When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases: For palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
      "Description": "DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL. Each mL of these preparations contains. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below. DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water."
    },
    {
      "NDCCode": "0009-0760-12",
      "PackageDescription": "1 BOTTLE in 1 CARTON (0009-0760-12)  / 100 mL in 1 BOTTLE",
      "NDC11Code": "00009-0760-12",
      "ProductNDC": "0009-0760",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin Pediatric",
      "NonProprietaryName": "Clindamycin Palmitate Hydrochloride",
      "DosageFormName": "GRANULE, FOR SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "19860417",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062644",
      "LabelerName": "Pharmacia & Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251111",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLEOCIN PEDIATRIC (clindamycin palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PEDIATRIC and other antibacterial drugs, CLEOCIN PEDIATRIC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride. CLEOCIN PEDIATRIC Flavored Granules contain clindamycin palmitate hydrochloride for reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, ethylparaben, pluronic F68, simethicone, sucrose."
    },
    {
      "NDCCode": "0009-3375-02",
      "PackageDescription": "2 CARTON in 1 PACKAGE (0009-3375-02)  > 12 BAG in 1 CARTON > 50 mL in 1 BAG (0009-3375-01) ",
      "NDC11Code": "00009-3375-02",
      "ProductNDC": "0009-3375",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cleocin Phosphate",
      "NonProprietaryName": "Clindamycin Phosphate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19900830",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA050639",
      "LabelerName": "Pharmacia and Upjohn Company LLC",
      "SubstanceName": "CLINDAMYCIN PHOSPHATE",
      "StrengthNumber": "12",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "19900830",
      "SamplePackage": "N"
    }
  ]
}
                    
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    <NDCCode>0009-0016-12</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0016-12)  / 4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00009-0016-12</NDC11Code>
    <ProductNDC>0009-0016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Solu-cortef</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19550427</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA009866</ApplicationNumber>
    <LabelerName>Pharmacia &amp; Upjohn Company LLC</LabelerName>
    <SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/4mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19550427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>0067-0016-24</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (0067-0016-24)  &gt; 12 PILL in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00067-0016-24</NDC11Code>
    <ProductNDC>0067-0016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ex-lax</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength Stimulant Laxative</ProprietaryNameSuffix>
    <NonProprietaryName>Sennosides</NonProprietaryName>
    <DosageFormName>PILL</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <EndMarketingDate>20181130</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
    <SubstanceName>SENNOSIDES</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20181130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0067-0016-48</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (0067-0016-48)  &gt; 12 PILL in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00067-0016-48</NDC11Code>
    <ProductNDC>0067-0016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ex-lax</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength Stimulant Laxative</ProprietaryNameSuffix>
    <NonProprietaryName>Sennosides</NonProprietaryName>
    <DosageFormName>PILL</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120101</StartMarketingDate>
    <EndMarketingDate>20181130</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
    <SubstanceName>SENNOSIDES</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120101</StartMarketingDatePackage>
    <EndMarketingDatePackage>20180930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0220-0016-12</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE, GLASS (0220-0016-12)</PackageDescription>
    <NDC11Code>00220-0016-12</NDC11Code>
    <ProductNDC>0220-0016</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Wormwood</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <StartMarketingDate>20170101</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Laboratoires Boiron</LabelerName>
    <SubstanceName>WORMWOOD</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10736-016-12</NDCCode>
    <PackageDescription>8750.9 L in 1 CYLINDER (10736-016-12)</PackageDescription>
    <NDC11Code>10736-0016-12</NDC11Code>
    <ProductNDC>10736-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Air</ProprietaryName>
    <NonProprietaryName>Air</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19630101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Medical-Technical Gases, Inc.</LabelerName>
    <SubstanceName>AIR</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>13668-016-12</NDCCode>
    <PackageDescription>120 TABLET in 1 BOTTLE (13668-016-12) </PackageDescription>
    <NDC11Code>13668-0016-12</NDC11Code>
    <ProductNDC>13668-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078858</ApplicationNumber>
    <LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam is indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below.       250 mg tablets: FD&amp;C Blue #2 Lake of indigo carmine.       500 mg tablets: Ferric oxide yellow.       750 mg tablets: Ferric oxide red and FD&amp;C #6 lake of sunset yellow. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>25682-016-12</NDCCode>
    <PackageDescription>12 VIAL in 1 CARTON (25682-016-12)  / 1 mL in 1 VIAL (25682-016-01) </PackageDescription>
    <NDC11Code>25682-0016-12</NDC11Code>
    <ProductNDC>25682-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Strensiq</ProprietaryName>
    <NonProprietaryName>Asfotase Alfa</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20151023</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125513</ApplicationNumber>
    <LabelerName>Alexion Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ASFOTASE ALFA</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).</IndicationAndUsage>
    <Description>Asfotase alfa is a tissue nonspecific alkaline phosphatase (TNSALP) produced by recombinant DNA technology in a Chinese hamster ovary cell line. Asfotase alfa is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human TNSALP, the human immunoglobulin G1 Fc domain and a deca-aspartate peptide used as a bone targeting domain. The two polypeptide chains are covalently linked by two disulfide bonds. STRENSIQ (asfotase alfa) injection is a sterile, preservative-free, nonpyrogenic, clear, slightly opalescent or opalescent, colorless to slightly yellow, with few small translucent or white particles, aqueous solution for subcutaneous administration. STRENSIQ is supplied in glass single-dose vials containing asfotase alfa; dibasic sodium phosphate, heptahydrate; monobasic sodium phosphate, monohydrate; and sodium chloride at a pH between 7.2 and 7.6. Table 5 describes the content of STRENSIQ vial presentations.</Description>
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  <NDC>
    <NDCCode>33342-016-12</NDCCode>
    <PackageDescription>100 TABLET in 1 CARTON (33342-016-12) </PackageDescription>
    <NDC11Code>33342-0016-12</NDC11Code>
    <ProductNDC>33342-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine</ProprietaryName>
    <NonProprietaryName>Amlodipine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201380</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>37000-016-12</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE, PLASTIC (37000-016-12)</PackageDescription>
    <NDC11Code>37000-0016-12</NDC11Code>
    <ProductNDC>37000-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pepto-bismol To Go</ProprietaryName>
    <NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part335</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
    <StrengthNumber>262</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-06-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>58933-016-12</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE, PLASTIC (58933-016-12) </PackageDescription>
    <NDC11Code>58933-0016-12</NDC11Code>
    <ProductNDC>58933-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pepto-bismol To Go</ProprietaryName>
    <NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part335</ApplicationNumber>
    <LabelerName>Procter &amp; Gamble Manufactura S de RL de CV</LabelerName>
    <SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
    <StrengthNumber>262</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>60429-016-12</NDCCode>
    <PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-016-12) </PackageDescription>
    <NDC11Code>60429-0016-12</NDC11Code>
    <ProductNDC>60429-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolic Acid</ProprietaryName>
    <NonProprietaryName>Mycophenolic Acid</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120821</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091558</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>MYCOPHENOLATE SODIUM</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141013</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1) . Use in combination with cyclosporine and corticosteroids. ( 1.1) .</IndicationAndUsage>
    <Description>Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as ( E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its molecular formula is C 17H 19O 6Na. The molecular weight is 342.32 g/mol and the structural formula is. Mycophenolic acid, as the sodium salt, is a white to off-white powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, hypromellose, methylcellulose, polyethylene glycol, sodium lauryl sulfate and stearic acid. The enteric coating of the tablet consists of ferric oxide red (360 mg), ferric oxide yellow, indigotine al lake (180 mg), methacrylic acid and ethyl acrylate copolymer dispersion, talc, titanium dioxide, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>63148-016-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE, PLASTIC (63148-016-12) </PackageDescription>
    <NDC11Code>63148-0016-12</NDC11Code>
    <ProductNDC>63148-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kitchen Lemon Zest Antibacterial Foaming Hand</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Apollo Health and Beauty Care Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for washing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>69771-016-12</NDCCode>
    <PackageDescription>5 g in 1 PACKET (69771-016-12) </PackageDescription>
    <NDC11Code>69771-0016-12</NDC11Code>
    <ProductNDC>69771-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Geri-gentle Petrolatum</ProprietaryName>
    <NonProprietaryName>White Petrolatum</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130923</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Geri-gentle corporation</LabelerName>
    <SubstanceName>PETROLATUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130923</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>70737-016-12</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (70737-016-12) </PackageDescription>
    <NDC11Code>70737-0016-12</NDC11Code>
    <ProductNDC>70737-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fluoride Dental Treatment Rinse</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211019</StartMarketingDate>
    <EndMarketingDate>20230930</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>DR Products</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20211019</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71819-016-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE, PLASTIC (71819-016-12) </PackageDescription>
    <NDC11Code>71819-0016-12</NDC11Code>
    <ProductNDC>71819-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dermaharmony Zinc Therapy</ProprietaryName>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210905</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>D3 Development, Inc.</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71930-016-12</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12) </PackageDescription>
    <NDC11Code>71930-0016-12</NDC11Code>
    <ProductNDC>71930-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quinidine Gluconate</ProprietaryName>
    <NonProprietaryName>Quinidine Gluonate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212589</ApplicationNumber>
    <LabelerName>Eywa Pharma Inc</LabelerName>
    <SubstanceName>QUINIDINE GLUCONATE</SubstanceName>
    <StrengthNumber>324</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-03-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Conversion of atrial fibrillation/flutter In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued. Reduction of frequency of relapse into atrial fibrillation/flutter Chronic therapy with quinidine gluconate is indicated for some patients at high risk of symptomatic atrial fibrillation/flutter, generally patients who have had previous episodes of atrial fibrillation/flutter that were so frequent and poorly tolerated as to outweigh, in the judgment of the physician and the patient, the risks of prophylactic therapy with quinidine gluconate. The increased risk of death should specifically be considered. Quinidine gluconate should be used only after alternative measures (e.g., use of other drugs to control the ventricular rate) have been found to be inadequate. In patients with histories of frequent symptomatic episodes of atrial fibrillation/flutter, the goal of therapy should be an increase in the average time between episodes. In most patients, the tachyarrhythmia will recur during therapy, and a single recurrence should not be interpreted as therapeutic failure. Suppression of ventricular arrhythmias Quinidine gluconate is also indicated for the suppression of recurrent documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of quinidine, its use with ventricular arrhythmias of lesser severity is generally not recommended, and treatment of patients with asymptomatic ventricular premature contractions should be avoided. Where possible, therapy should be guided by the results of programmed electrical stimulation and/or Holter monitoring with exercise. Antiarrhythmic drugs (including quinidine gluconate) have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
    <Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2  C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, alcohol and sodium alginate. Meets USP Dissolution Test 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>73212-016-12</NDCCode>
    <PackageDescription>100 g in 1 BOTTLE (73212-016-12) </PackageDescription>
    <NDC11Code>73212-0016-12</NDC11Code>
    <ProductNDC>73212-016</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Thymosin Beta-4 Acetate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200801</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
    <SubstanceName>THYMOSIN .BETA.-4</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-12</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-AUG-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>73774-016-12</NDCCode>
    <PackageDescription>.035 kg in 1 POUCH (73774-016-12) </PackageDescription>
    <NDC11Code>73774-0016-12</NDC11Code>
    <ProductNDC>73774-016</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20230101</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>SHAKTI LIFESCIENCE PRIVATE LIMITED</LabelerName>
    <SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <DEASchedule>CIII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2026-05-11</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>12-JAN-24</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>74743-016-12</NDCCode>
    <PackageDescription>3800 g in 1 BOTTLE (74743-016-12) </PackageDescription>
    <NDC11Code>74743-0016-12</NDC11Code>
    <ProductNDC>74743-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Alcohol Free Sanitizing</ProprietaryName>
    <NonProprietaryName>Alcohol Free Sanitizing</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200420</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Guangzhou Joy Claire Biological Technology Co., Ltd</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE; POLYAMINOPROPYL BIGUANIDE</SubstanceName>
    <StrengthNumber>.04; .1</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sanitizing for surfaces of hard objects in hospitals, homes and public areas, full skin surface,surgeres, fabrics and other surfaces of porous objects.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75086-016-12</NDCCode>
    <PackageDescription>3800 mL in 1 BOTTLE (75086-016-12) </PackageDescription>
    <NDC11Code>75086-0016-12</NDC11Code>
    <ProductNDC>75086-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Air Raid Card Wash Free Disinfectant</ProprietaryName>
    <NonProprietaryName>Air Raid Card Wash Free Disinfectant</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200420</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Jiangsu Manwei Pharmaceutical Co.,Ltd</LabelerName>
    <SubstanceName>HYPOCHLOROUS ACID</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>80948-016-12</NDCCode>
    <PackageDescription>4 BOTTLE in 1 PACKAGE (80948-016-12)  / 80 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>80948-0016-12</NDC11Code>
    <ProductNDC>80948-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Puroma Foaming Hand Sanitizer Alcohol Free With Fragrance Floral</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210427</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>ZENITH MICRO CONTROL</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps eliminate bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>82804-016-12</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE (82804-016-12) </PackageDescription>
    <NDC11Code>82804-0016-12</NDC11Code>
    <ProductNDC>82804-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230508</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231004</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Phenazopyridine HCL is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).</IndicationAndUsage>
    <Description>Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl oral tablets contain the following inactive ingredients: Croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, maize (corn starch), microcrystalline cellulose, polyethylene glycol, povidone and pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>83511-016-12</NDCCode>
    <PackageDescription>.001 kg in 1 DRUM (83511-016-12) </PackageDescription>
    <NDC11Code>83511-0016-12</NDC11Code>
    <ProductNDC>83511-016</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Clemastine Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20250929</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>STHREE CHEMICALS PRIVATE LIMITED</LabelerName>
    <SubstanceName>CLEMASTINE FUMARATE</SubstanceName>
    <StrengthNumber>35</StrengthNumber>
    <StrengthUnit>kg/35kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-10</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>29-SEP-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83629-016-12</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE, PLASTIC (83629-016-12) </PackageDescription>
    <NDC11Code>83629-0016-12</NDC11Code>
    <ProductNDC>83629-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nexxgen 91% Rubbing Alcohol</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>A &amp; A Nexxgen LLC</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>91</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> first aid to help prevent the risk of infection in minor cuts, scrapes and burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>83702-016-12</NDCCode>
    <PackageDescription>6 PATCH in 1 BAG (83702-016-12)  / 2.1 g in 1 PATCH (83702-016-11) </PackageDescription>
    <NDC11Code>83702-0016-12</NDC11Code>
    <ProductNDC>83702-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Rotosxika Varicoce Veins Plaster</ProprietaryName>
    <NonProprietaryName>Aesculus Chinensis, Arnica</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230601</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Puning Xinhua Trade Co., Ltd.</LabelerName>
    <SubstanceName>AESCULUS CHINENSIS WHOLE; ARNICA CORDIFOLIA WHOLE</SubstanceName>
    <StrengthNumber>4; 3</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use to: Temporarily alleviate discomfort related to varicose veins: lower limb spasms, limb soreness, venous dilation, venous congestion, leg fatigue.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84165-016-12</NDCCode>
    <PackageDescription>12 BAG in 1 BOX (84165-016-12)  / 21 g in 1 BAG (84165-016-01) </PackageDescription>
    <NDC11Code>84165-0016-12</NDC11Code>
    <ProductNDC>84165-016</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sumifun Lidocaine Pain Relief Gel-patch</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250829</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Guangzhou Zhupuyou E-commerce Co., Ltd</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>.04</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250829</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders,elbows.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0009-0171-12</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (0009-0171-12)</PackageDescription>
    <NDC11Code>00009-0171-12</NDC11Code>
    <ProductNDC>0009-0171</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Micronase</ProprietaryName>
    <NonProprietaryName>Glyburide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840501</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017498</ApplicationNumber>
    <LabelerName>Pharmacia and Upjohn Company</LabelerName>
    <SubstanceName>GLYBURIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2014-07-14</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>0009-0306-12</NDCCode>
    <PackageDescription>25 VIAL, MULTI-DOSE in 1 PACKAGE (0009-0306-12)  / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>00009-0306-12</NDC11Code>
    <ProductNDC>0009-0306</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Depo-medrol</ProprietaryName>
    <NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE</RouteName>
    <StartMarketingDate>19590528</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA011757</ApplicationNumber>
    <LabelerName>Pharmacia &amp; Upjohn Company LLC</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19590528</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases: For palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
    <Description>DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL. Each mL of these preparations contains. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below. DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.</Description>
  </NDC>
  <NDC>
    <NDCCode>0009-0760-12</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0009-0760-12)  / 100 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00009-0760-12</NDC11Code>
    <ProductNDC>0009-0760</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cleocin Pediatric</ProprietaryName>
    <NonProprietaryName>Clindamycin Palmitate Hydrochloride</NonProprietaryName>
    <DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19860417</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062644</ApplicationNumber>
    <LabelerName>Pharmacia &amp; Upjohn Company LLC</LabelerName>
    <SubstanceName>CLINDAMYCIN PALMITATE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CLEOCIN PEDIATRIC (clindamycin palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PEDIATRIC and other antibacterial drugs, CLEOCIN PEDIATRIC should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The structural formula is represented below. The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride. CLEOCIN PEDIATRIC Flavored Granules contain clindamycin palmitate hydrochloride for reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, ethylparaben, pluronic F68, simethicone, sucrose.</Description>
  </NDC>
  <NDC>
    <NDCCode>0009-3375-02</NDCCode>
    <PackageDescription>2 CARTON in 1 PACKAGE (0009-3375-02)  &gt; 12 BAG in 1 CARTON &gt; 50 mL in 1 BAG (0009-3375-01) </PackageDescription>
    <NDC11Code>00009-3375-02</NDC11Code>
    <ProductNDC>0009-3375</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cleocin Phosphate</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19900830</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050639</ApplicationNumber>
    <LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19900830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>0009-0016-12</NDCCode><ProprietaryName>Solu-cortef</ProprietaryName><NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName></NDC><NDC><NDCCode>0067-0016-24</NDCCode><ProprietaryName>Ex-lax</ProprietaryName><NonProprietaryName>Sennosides</NonProprietaryName></NDC><NDC><NDCCode>0067-0016-48</NDCCode><ProprietaryName>Ex-lax</ProprietaryName><NonProprietaryName>Sennosides</NonProprietaryName></NDC><NDC><NDCCode>0220-0016-12</NDCCode><NonProprietaryName>Wormwood</NonProprietaryName></NDC><NDC><NDCCode>10736-016-12</NDCCode><ProprietaryName>Air</ProprietaryName><NonProprietaryName>Air</NonProprietaryName></NDC><NDC><NDCCode>13668-016-12</NDCCode><ProprietaryName>Levetiracetam</ProprietaryName><NonProprietaryName>Levetiracetam</NonProprietaryName></NDC><NDC><NDCCode>25682-016-12</NDCCode><ProprietaryName>Strensiq</ProprietaryName><NonProprietaryName>Asfotase Alfa</NonProprietaryName></NDC><NDC><NDCCode>33342-016-12</NDCCode><ProprietaryName>Amlodipine</ProprietaryName><NonProprietaryName>Amlodipine</NonProprietaryName></NDC><NDC><NDCCode>37000-016-12</NDCCode><ProprietaryName>Pepto-bismol To Go</ProprietaryName><NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName></NDC><NDC><NDCCode>58933-016-12</NDCCode><ProprietaryName>Pepto-bismol To Go</ProprietaryName><NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName></NDC><NDC><NDCCode>60429-016-12</NDCCode><ProprietaryName>Mycophenolic Acid</ProprietaryName><NonProprietaryName>Mycophenolic Acid</NonProprietaryName></NDC><NDC><NDCCode>63148-016-12</NDCCode><ProprietaryName>Kitchen Lemon Zest Antibacterial Foaming Hand</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>69771-016-12</NDCCode><ProprietaryName>Geri-gentle Petrolatum</ProprietaryName><NonProprietaryName>White Petrolatum</NonProprietaryName></NDC><NDC><NDCCode>70737-016-12</NDCCode><ProprietaryName>Fluoride Dental Treatment Rinse</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>71819-016-12</NDCCode><ProprietaryName>Dermaharmony Zinc Therapy</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>71930-016-12</NDCCode><ProprietaryName>Quinidine Gluconate</ProprietaryName><NonProprietaryName>Quinidine Gluonate</NonProprietaryName></NDC><NDC><NDCCode>73212-016-12</NDCCode><NonProprietaryName>Thymosin Beta-4 Acetate</NonProprietaryName></NDC><NDC><NDCCode>73774-016-12</NDCCode><NonProprietaryName>Testosterone Cypionate</NonProprietaryName></NDC><NDC><NDCCode>74743-016-12</NDCCode><ProprietaryName>Alcohol Free Sanitizing</ProprietaryName><NonProprietaryName>Alcohol Free Sanitizing</NonProprietaryName></NDC><NDC><NDCCode>75086-016-12</NDCCode><ProprietaryName>Air Raid Card Wash Free Disinfectant</ProprietaryName><NonProprietaryName>Air Raid Card Wash Free Disinfectant</NonProprietaryName></NDC><NDC><NDCCode>80948-016-12</NDCCode><ProprietaryName>Puroma Foaming Hand Sanitizer Alcohol Free With Fragrance Floral</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>82804-016-12</NDCCode><ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName><NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>83511-016-12</NDCCode><NonProprietaryName>Clemastine Fumarate</NonProprietaryName></NDC><NDC><NDCCode>83629-016-12</NDCCode><ProprietaryName>Nexxgen 91% Rubbing Alcohol</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>83702-016-12</NDCCode><ProprietaryName>Rotosxika Varicoce Veins Plaster</ProprietaryName><NonProprietaryName>Aesculus Chinensis, Arnica</NonProprietaryName></NDC><NDC><NDCCode>84165-016-12</NDCCode><ProprietaryName>Sumifun Lidocaine Pain Relief Gel-patch</ProprietaryName><NonProprietaryName>Lidocaine</NonProprietaryName></NDC><NDC><NDCCode>0009-0171-12</NDCCode><ProprietaryName>Micronase</ProprietaryName><NonProprietaryName>Glyburide</NonProprietaryName></NDC><NDC><NDCCode>0009-0306-12</NDCCode><ProprietaryName>Depo-medrol</ProprietaryName><NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName></NDC><NDC><NDCCode>0009-0760-12</NDCCode><ProprietaryName>Cleocin Pediatric</ProprietaryName><NonProprietaryName>Clindamycin Palmitate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0009-3375-02</NDCCode><ProprietaryName>Cleocin Phosphate</ProprietaryName><NonProprietaryName>Clindamycin Phosphate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

  • Use the domain parameter to specify required data domain.
  • Use the operation parameter to specify “format_check” operation.
  • Use the q (query) parameter to specify your query.
  • Use the token (API key) query parameter to identify your application.

Optional parameter:

  • Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

  • Use the domain parameter to specify required data domain.
  • Use the operation parameter to specify “format_check” operation.
  • Use the q (query) parameter to specify your query.
  • Use the token (API key) query parameter to identify your application.
  • Use the tin (tin number) parameter to specify your query about tin number.
  • Use the tinname (tin name) parameter to specify your query about tin name.
  • Use the zipcode (zip code) parameter to specify your query about zip code.
  • Use the radius (radius) parameter to specify your query about radius.
  • Use the fromdate (fromdate) parameter to specify your query about from date.
  • Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

  • check_status — this method allows to get current code status.
  • getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
  • getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
  • search — allows retrieval of set of items based on the free-form lookup query.
  • search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

  • validate — allows to determine whether provider's information is valid based on data in the CMS database.
  • paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
  • search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
  • zipradius — allows to get npis by zipcode & radius.
  • npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) based on the free-form lookup query.
    • search_and_keywords - returns not only free-form lookup results but also keywords relevant to the original query.
    • getcode - this method allows retrieval of full infrormation regarding one item based on the provided key.
    • getcodes - this method allows retrieval of full infrormation regarding number of items based on the provided keys.
  • NPI-specific operations:
    • validate — allows to determine whether provider's information is valid based on data in the CMS database.
    • paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
    • search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
    • zipradius — allows to get npis by zipcode & radius.
    • npideactivated — allows to get deactivated npis between two dates.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

Output

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
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      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

Output

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
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}
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